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Just because a study uses humans does not mean that it constitutes human subjects research. The following activities generally do not require review by the UCAIHS as they do not fit either or both of the federal definitions for research and human subject:

· Data collected for internal departmental, school, or other Institutional administrative purposes such as: teaching evaluations or customer service surveys;

· interviews or survey research where questions focus on things, products, or policies rather than about people or their thoughts regarding themselves, such as canvassing librarians about inter-library loan policies or rising journal costs. Note: If you are asking a person’s opinion, it could be human subjects research.

· Activities designed specifically for educational or teaching purposes, such as a research methods course where any data that is collected from and about people is part of a class exercise or assignment, but will not be used or disseminated outside of the classroom setting.

· Documentaries, oral history and biographical interviews do not constitute research as defined by the federal regulations as they are not generalizeable. Their intent is to document specific historical events or the experiences of individuals or communities over different time periods and generally do not lead to the development of a hypothesis in a manner that would have a predictive value (information obtained cannot be applied or generalized to another group). Researchers are advised to contact the UCAIHS to ensure that any proposed interviews actually constitute oral history research or biographic interviews.

· Research using cadavers, autopsy material or bio-specimens from deceased individuals is not human subjects research.Note: Some research in this category, such as genetic studies which also use private or medical information obtained from living relatives of the decedents may need IRB review. Please contact the UCAIHS for further information.

· Clinical case histories which are published and/or presented at national or regional meetings are not research ifthe case is limited to a description of the clinical features and/or outcome of a single patient and do not intend to contribute to generalizable knowledge.

· Publicly available data do not require UCAIHS review. Examples: census data, labor statistics. Note: Investigators should contact the UCAIHS if they are unsure if their data qualifies as "publicly available."

· Coded specimens and/or data sets that were not collected for the currently proposed projects do not need UCAIHS review as long as the investigator receiving the data/specimens cannot link the data/specimens back to individual subjects. If the data/specimen provider can ascertain the identity of the subjects (e.g. subjects' names, addresses, etc.), the investigator must enter into an agreement with the data/specimen provider that states under no circumstances will the identity of the subjects be released to the investigator.

Below are sample consent forms that may be used as a template for Minimal Risk surveys on Non-Protected Populations. The information in brackets must be provided but feel free to alter the remaining text to suit your particular needs.

Telephone Script

Hello, my name is [INSERT NAME] from [INSERT INSTITUTION]. I am calling to ask if you would be interested in participating in a research study about [INSERT PURPOSE OF THE STUDY]. It will take approximately [INSERT TIME]. Is this a good time to talk? (If not, ask for a different time). Your responses will be kept confidential, I have not written down your name or phone number on the answer sheet. Feel free to skip any questions that you do not want to answer. Let me give you a number where I can be reached if you have any questions after the study is over [INSERT CONTACT NUMBER]. Are you ready to begin?

Internet Survey Script

Hello, my name is [INSERT NAME] from [INSERT INSTITUTION]. I am a conducting a research study about [INSERT PURPOSE OF THE STUDY]. Would you be willing to take [INSERT TIME] to fill out the survey attached to this introduction? Your responses will be anonymous; there is no way for me to know who filled a survey. Feel free to skip any questions that you do not want to answer. If you have questions about the survey, please feel free to email me at [INSERT CONTACT INFORMATION] (you may also include a phone number or use a phone number instead of an email address). If you choose to participate, please click on I ACCEPT at the bottom of the screen to begin the survey. Thank you in advance for your time.

Pen and Paper Survey Script

Hello, my name is [INSERT NAME] from [INSERT INSTITUTION]. I am conducting a research study about [INSERT PURPOSE OF THE STUDY]. Would you be willing to take [INSERT TIME] to fill out the survey? Your responses will be anonymous; there is no way for me to know who filled a survey. Feel free to skip any questions that you do not want to answer. If you have questions about the survey, please feel free to email me at [INSERT CONTACT INFORMATION] (you may also include a phone number or use a phone number instead of an email address). If you choose to participate, please take a survey packet that includes an self-addressed envelope you can use to mail me the survey. (If appropriate, use “please deposit your survey in the drop box located at [INSERT LOCATION]”). Thank you in advance for your time.

3. Once you have read the submission instructions and guidance, check this page for other FAQs that might apply. Before submitting your application you should meet and review all your documents with your faculty sponsor (if applicable). If you are still unclear on the need for the type of IRB review, we recommend sending your questions to ask.humansubjects@nyu.edu. You are also welcome to attend one of the UCAIHS drop-in consultation sessions for guidance from the IRB staff. While NOT REQUIRED, many problems encountered by first time researchers can be avoided with a little help from the UCAIHS staff.

2) Projects that do not meet the criteria for exempt review but are also minimal risk research on non-protected populations may be eligible for expedited review. For a list of expedited review categories seehttp://www.hhs.gov/ohrp/policy/expedited98.html.

3) Projects that are more than minimal risk and/or on vulnerable/protected populations are not eligible for either expedited or exempt review and require a full board review. For further information on more than minimal risk, including examples see Convened/Full Board Review. If you are using vulnerable/protected populations there may be additional review requirements:

If your project involves direct contact with the subjects you need a description of the research that could take the form of a consent form, or a project summary statement, (which is exactly like a consent form, except there is no signature necessary) or a short form project statement. Templates of the consent form, and short form are available under the forms section.

A copy of a recruitment script, for example what you will say to people who telephone or email you asking about the study,

A copy of all survey instruments/interview protocols, interview guides, and questionnaires,

Letters of support from cooperating institutions, including schools (which also requires Board of Education approval for NYC schools), churches, social groups, city agencies, other universities etc. These all must be on appropriate letterhead and signed by the appropriate person. It is the researcher’s responsibility to determine when cooperating institutions letters are necessary as well as determining who is the appropriate person to sign.

Note: You may submit your application with these letters “pending’, but you will need to provide hard copies prior to getting your proposal formally approved, and you may not begin research until the hard copies have been received by the committee.

If the research involves deception, then a de-briefing statement that describes the deception must also be included.

Probably a bad idea. Because of changing federal requirements, the consent form and application get revised at regular intervals and if you use an old application/consent form, there is a good chance that you will have to re-do the application/consent using the new version. Please get the latest versions of the forms and guidances.

Explaining your research project in sufficient detail so that the reviewers can determine the level of risk. Remember that risk includes more than physical harm. For social, educational, and behavioral research risks include:

Psychological: risks that may be experienced during participation in the research and/or afterwards as a result of participating in the research. These risks include anxiety, stress, fear, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, and/or altered behavior.

Social/Economic: risks that include alterations in relationships with others that are to the disadvantage of the subject, and may involve embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject’s opportunities and status in relation to others. These risks include payment by subject’s for procedures, loss of wages or income, and/or damage to employability or insurability.

Legal: include risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally liable.

Loss of Confidentiality: Confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Risks from breach of confidentiality include invasion of privacy, as well as the social, economic and legal risks outlined above. Loss of confidentiality is the most common type of risk encountered in social and behavioral science research.

To the extent that you can reduce, eliminate, or in other ways mitigate these risks, your research will benefit, and the review process will proceed much more rapidly.

The UCAIHS generally allows IRB reviewers up to two weeks to review an application (including weekends) or ten business days, although review time may take longer especially around holidays, spring break and during the summer months. However, it is rare if a PI doesn’t receive some type of communication from the UCAIHS within this time frame, unless the protocol requires a full board review. This may take more time since it requires the entire IRB committee to meet and discuss.

If you receive a request for modifications and/or additional information notice, please be aware that there will be time between your reply to the reviewers and an approval.

Investigators are always welcome to call 212-998-4808 or email ask.humansubjects@nyu.edu the UCAIHS with questions or concerns.

Most applications are logged by the UCAIHS and acknowledged within 24 hours of receipt (except on weekends or holidays). If you do NOT receive a confirmation email within 48 hours please call the UCAIHS office at 212-998-4808.

Specific Questions

Although your student may be doing the research, as the faculty sponsor you are responsible for ensuring appropriate research design when human subjects are involved and for assisting in development of the application to the University Committee on Activities Involving Human Subjects. In addition, you have responsibility for his or her conduct in the field, adherence to the protocol, and any adverse events or problems that may occur. You should also be able to appropriately address any questions from subjects concerning their rights as a subject or potential violations of such rights.

There are three methods to deal with undergraduate student (classroom) research.

If the data will not be used outside the classroom ,e.g., an in-class presentation is the only time the data will be presented, then no IRB oversight is needed;

If the data may be used for other purposes (a dissertation, preliminary data for a grant, presentation outside the classroom) and the projects are minimal risk then there are two options for the faculty member to file “blanket” applications;

If the data may be used for other purposes (a dissertation, preliminary data for a grant, presentation outside the classroom) and the project is more than minimal risk, a full application must be prepared and the faculty must show how risks to the research subject will be minimized and demonstrate plans for close oversight of the research. Because it is the responsibility of the IRB committee to document the qualifications of the researcher to perform the research, for undergraduates the committee may require additional information on the student from the faculty sponsor.

Research planned on non-prison populations can be continued if a subject becomes incarcerated, if the following conditions are met:

The IRB is notified within 72 business hours of the investigator becoming aware that a subject is incarcerated. Notification by email, followed by a signed hard copy is acceptable. Data collection must cease; the investigator may request that data collection continue and provide justification that it is in the best interest of the prisoner for the research to continue. (This will primarily be confined to interventional research). If granted, then data collection may continue during the period while the amendment is processed. This request should be made to the IRB.

An amendment is filed that includes an additional consent form with the necessary language to reflect the altered conditions (see link). Board review of the amendment is a full board review with the specially constituted board. No data collection may occur until the full board has approved the project.

TIMELINE: Because prisoner research requires a prisoner advocate, a minimum of two months should be allowed for research review. Please contact UCAIHS when submitting a new or amended proposal so that the representative can be scheduled into a meeting as soon as possible.

The UCAIHS will notify the principal investigator of soonest review date possible.

Category 1 Exempt Status Does not apply to studies where the investigator is taking part in the classroom activities OR if activities are introduced for the purpose of the proposed project and are not a part of the usual curriculum or activities.

Examples:

If you add an activity or exercise for the purpose of your research, you cannot use category 1.

If you modify the curriculum for research purposes, you cannot use category 1.

If you participate in classroom activities with your students, you cannot use category 1.

Risks are of many kinds: physical harm, emotional distress, exposure to legal action, damage to employability, insurance qualification or standing in the community. One of the most significant sources of risk is a breach of confidentiality.

Unless a subject gives explicit permission as part of the consent process, everything that a subject reveals to an investigator or the research staff must be held confidential through both the discretion of the investigators and the physical protection of the information collected. Any breach of confidentiality, especially if it is of sensitive information (such as illegal behavior, undocumented immigration status, alcohol or drug use, sexual practices or preferences, presence of serious health problems) represents a potentially serious risk to a subject. At times, just the fact that an individual is part of a study can be a source of significant risk to that person, particularly if the study concerns sensitive topics such as health status or sexual behavior.

Instructors may submit an application for a blanket exemption for their class one of two ways, described below. In both cases, the applications will be reviewed by the UCAIHS sub-Committee as with all other exempt proposals.

The instructor may develop a small set of clearly defined research assignments, all of which fall into exempt categories, from which all students will select a project. In such cases, in which a limited number of research topics are defined by the instructor, the application for the blanket exemption should include: the list of topics, standard recruitment procedures and materials, a standardized consent process and materials, and questionnaires, surveys or other materials to be used by members of the class.

The instructor may also decide to allow students in the course to each develop their own research project, but must make sure that all clearly fall into an exempt category. Projects that are deemed more than minimum risk, such as projects on sensitive topics, e.g., self-worth, family/personal problems, ethnicity, sexual behavior or orientation, or illegal activities, are NOT eligible for exempt status and cannot be included in a blanket application. The instructor will then submit an application that includes for each student: a one or two page statement giving the purpose of the research, the composition and number of subjects expected; how recruitment will be done; a copy of any proposed recruitment materials and the proposed consent materials. The application should also include any material that will be used for the projects, such as interview protocols, surveys or questionnaires and must provide cooperating organization letters, if applicable. Once the UCAIHS determines that the proposed projects meet the criteria for exempt review, individual student projects are reviewed, revised and approved individually."

The Progress Report should be a presentation of your research accomplishments during of the previous year, in lay language.

Suggested Format:

Goals:
Are the current goals the same as you originally proposed? If the goals have not been changed, say so. If the goals have been changed, state the revised goals and the reason for the modification (this generally should be supported by modifications on file with the application or you should propose a modification in the progress report).

Results:
Describe how the research is achieving the goals during the current approval period and the results obtained. Include negative results. If technical problems were encountered in carrying out this research, describe how your approach was modified.

Significance:
Emphasize the significance of the findings to the field and their potential impact.

Plans:
Summarize your plans to address the goals during the next approval period. Include any important modifications to the original plans.

Human Subjects:
If not apparent in the body of your report, please describe how your use of human subjects has changed, if at all. Include any proposed changes to your recruitment procedures, data collection procedures, etc.

Submit an amendment to the existing approved application adding the individual(s). Choose a title that describes what the individual's role is (e.g., interviewer, research trainee, etc.). In addition, please complete Appendix A: Additional NYU Co-Investigators & Personnel and submit it along with the amendment application. Both the amendment application and Appendix A are available on the UCAIHS web site’s Forms and Guidance page.

Any person enrolled or likely to be enrolled in the near future in classes or seminars of the investigator, OR

Any person being advised, mentored or supervised by the investigator or who has the investigator on their advisory committee

If there is no other subject population that would be suitable, then the following conditions must be fulfilled to meet federal regulations on potentially vulnerable populations:

Recruitment for the study, distribution and collection of the material must be made by a third party

For student research third party status does not include: Members of the investigator’s laboratory, Teaching assistants for the course

Recruitment must be delayed

Recruitment by the third party should begin after all grades for the course or series of courses have been submitted or the students have graduated

As an alternative to delayed recruitment, for research on students, delayed data analysis may be acceptable: It is possible to use materials collected during the course but only after the students have received their grade or graduated from the program.

Final Notes

Because of the requirement for anonymity for both student/employee research, specific types of research do not meet federal guidelines, including but not necessarily limited to, interviews, including interviews by a third party that would be audio taped or video taped, focus groups, surveys containing identifiers or surveys in a population of insufficient size to guarantee anonymity.

Any person who receives a regular paycheck or other form of reimbursement from the investigator or the supervisors of the investigator,

or

Any person who has applied for a position with the investigator or subordinate of the investigator.

If there is no other subject population that would be suitable, then the following conditions must be met to meet federal regulations on potentially vulnerable populations:

Recruitment for the study, distribution and collection of the material must be made by a third party

For employee research third party status does not include:

Co-workers of equivalent rank who report to the investigators

Co-workers who report to the investigators’ superior

Human Resources personnel

The employee population must be sufficiently large that anonymous surveys cannot be linked with individual respondents.

Final Notes

Because of the requirement for anonymity for both student/employee research, specific types of research do not meet federal guidelines, including but not necessarily limited to, interviews, including interviews by a third party that would be audio taped or video taped, focus groups, surveys containing identifiers or surveys in a population of insufficient size to guarantee anonymity.

Student Involvement in Human Subjects Research

Students who pose their own research questions or test hypotheses should submit their own applications (request for exemption, minimal risk/expedited, or full review). Typically, because many students work on existing data sets and have no contact with human subjects, these applications will meet exemption criteria. If the application does not meet exemption criteria, it is likely that it can be reviewed under expedited review procedures.

It depends. Yes- if the student will be involved with human subjects or identifiable data obtained from humans. No- If the student is simply doing a paid job, will not be developing research questions or testing hypotheses and, thus, not co-authoring publications, has no contact with subjects, and does not have access to subject identifiers, it is not necessary to name the student on existing approvals.

Yes. All persons who have contact with subjects (thus, all interviewers), and those who have access to personally identifiable information, must be named on the human subjects application. As individuals are hired, they can be added via an amendment form. However, it is not necessary to name people hired to do specific tasks, even when these tasks require access to the data (e.g., statisticians), provided the data do not have identifiers and there will be no contact with subjects.

If the student co-authors papers for presentation or publication, the UCAIHS considers him/her to be equivalent to an investigator on the project and s/he should be named on the human subjects application. Submit an amendment to the existing application naming the student as a co-investigator.

Submit an amendment to the existing approved application adding the student. Choose a title that describes what the student's role is (e.g., interviewer, research trainee, etc.). In addition, please complete Appendix A: Additional NYU Co-Investigators & Personnel and submit it along with the amendment application. Both the amendment application and Appendix A are available on the UCAIHS web site’s Forms and Guidance page.

Yes. In addition to faculty research human subjects committee review and approval is required for theses and dissertations, and some undergraduate research. Once you have decided on your research topic, read the information on this website about the three levels of review (exempt, expedited and full board). Contact the UCAIHS office with any study-specific questions and also review the appropriate sections of this website to help you determine which level is needed. Note that if a study requires review at a convened meeting (full board review) you must allow adequate time for the review (up to three months depending on the subject population, potential risks to the study subjects and if cooperating institutions are engaged in the research).

Yes. Students who pose their own research questions or test hypotheses using secondary data can (1) submit a request for exemption, expedited or full review, whichever is appropriate, or (2) receive clearance under a blanket application (prepared and submitted by the instructor) covering these projects (generally for exempt research). Contact the UCAIHS for more information about a blanket application.

No. The intent of a project is critical to determining whether human subjects approval is needed. If the intent is to teach a research skill (e.g., how to interview), and not to produce generalizable findings, then human subjects clearance is not necessary.